NEW THERAPEUTIC ENTITIES
Which pathway? In this context, it is still not entirely clear what pathway is more appropriate to use for filing/approving NTE applications
for
MA. The debate is between submitting applications covered by section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, for the development of novel formulations and new combinations, or section 505(j), for generic drug applications. Te first route, 505(b)(2), is particularly
attractive to generic-based companies seeking to pursue NTE status, since it may provide a three-year period of market exclusivity. However, what happens when it comes to
seeking IP protection for a recently generated NTE? It is quite easy to recognise innovative drugs as being novel, being a produce of an inventive step, and having ample industrial applicability—ie, exactly the opposite of generic drugs. In fact, these three qualities are precisely the globally-recognised major requirements for an invention to be patented. Novelty implies that the invention or
improvement must not have been disclosed, orally or in writing, and not used in an industrial process, anywhere in the world before the filing date of the application.
“THE CHALLENGE BECOMES PROVING THAT SUCH
PROCESSES REALLY INVOLVE SOME EXTENT OF CREATIVE INPUT AND THAT NONE OF THE EXISTING METHODS WOULD ANTICIPATE THE RESULTING ADDED- VALUE GENERIC.”
Similarly, for an invention to be the product
of an inventive step, it must not be obvious or deductible to a person skilled in the art when using the information disclosed anywhere in the world on the filing date. An invention is accepted as having industrial applicability,
in general terms, if it is useful in a production process. Te question that comes to mind is whether NTEs, understood as supergenerics, are entirely qualified to be patented under the current local IP protection schemes. Tere is not a definite answer and in fact, a few gatherings of specialists worldwide have been taking place to discuss this matter. First, there definitely seems to be a novelty
obstacle with NTEs, precisely because they use a drug or group of drugs that are already known. Mexican patent
law, for example, is
very clear on this point. Article 19, fraction VIII of the Industrial Property Law states that “the juxtaposition of known inventions or mixtures of known products, the variation in their use, form, dimensions or materials, except that in reality they are combined or merged so they cannot function separately or that the qualities or functions thereof are modified to obtain an industrial result or use not obvious to a person skilled in the art” are not considered inventions. Under this premise, it would seem that NTEs cannot truly be considered as novel inventions. Furthermore, interested manufacturers
argue that an NTE’s inventive step is salvaged by means of modifying the drug’s formulation,
86 World Intellectual Property Review Annual 2015
World Intellectual Property Review November/December 2014
www.worldipreview.com
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